A two-arm phase II randomised trial of intermittent chemotherapy plus continuous cetuximab and of intermittent chemotherapy plus intermittent cetuximab in first line treatment of patients with K-ras-normal (wild-type) metastatic colorectal cancer

Medical Research Council (MRC) (UK)0 sites130 target enrollmentJanuary 4, 2007

Overview

Registry

who.int

Start Date

January 4, 2007

End Date

June 1, 2010

Last Updated

4 years ago

Study Type

Interventional

Sex

All

Sponsor

Medical Research Council (MRC) (UK)

•Amended as of 17/02/2009:
•1\. Written informed consent
•2\. Consent for screening of an archival formalin\-fixed paraffin embedded (FFPE) tumour block for determination of K\-ras status, with only patients with only K\-raswt tumours being eligible for randomisation
•3\. Once K\-raswt status confirmed, written informed consent for participation in the trial
•4\. Patients at least 18 years or over, either sex
•5\. Confirmed colorectal adenocarcinoma:
•5\.1\. Either previous or current histologically\-confirmed primary adenocarcinoma of colon or rectum, together with clinical or radiological evidence of current advanced and/or metastatic disease, or
•5\.2\. Histologically/cytologically\-confirmed metastatic adenocarcinoma, together with clinical and/or radiological evidence of colorectal primary tumour
•6\. Inoperable metastatic or locoregional disease
•7\. Patients with potentially resectable liver metastases are eligible (see exclusion criteria)

•Amended as of 17/02/2009:
•1\. Patients who have a confirmed K\-ras mutation in their tumour post screening
•2\. Patients who are receiving combination chemotherapy prior to the planned resection of operable liver metastases (defined as less than 4 unilobar liver metastases, each less than 4 cm in size and without major vascular involvement). Patients outside these criteria are of uncertain operability and are eligible.
•3\. Patients who have received any prior chemotherapy with oxaliplatin
•4\. Patients who are unfit for the chemotherapy regimens in this protocol, e.g.:
•4\.1\. Severe uncontrolled concurrent medical illness (including poorly controlled angina or very recent myocardial infarction \[MI], i.e. in previous 12 weeks) likely to interfere with protocol treatments
•4\.2\. Any psychiatric or neurological condition which is felt likely to compromise the patient's ability to give informed consent or to comply with oral medication
•4\.3\. Partial or complete bowel obstruction
•4\.4\. Pre\-existing neuropathy (greater than Grade 1\)
•5\. Patients requiring ongoing treatment with a contraindicated concomitant